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BJOG. 2018 Nov;125(12):1581-1589. doi: 10.1111/1471-0528.15388. Epub 2018 Jul 20.

Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai-VTE study.

Author information

1
Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.
2
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.
3
Department Medicine and Surgery, University of Insubria, Varese, Italy.
4
Department of Medicine I Clinical Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.
5
Department of Medicine I, Medical University of Vienna, Vienna, Austria.
6
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, Amsterdam, the Netherlands.
7
Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
8
Thrombosis & Thrombophilia, Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK.
9
Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
10
1st Medical Department, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Heidelberg, Germany.
11
Division of Angiology and Haemostasis, Department of Specialties of Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
12
Department of Internal Medicine and Chest Diseases, Center Hospitalier Universitaire de Brest, Hôpital de la Cavale Blanche, Brest, France.

Abstract

OBJECTIVE:

To investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE).

DESIGN AND SETTING:

Post hoc analysis of the Hokusai-VTE study, a multicentre, randomised, double-blind trial comparing edoxaban with warfarin for acute symptomatic VTE.

POPULATION:

Women below 50 years receiving edoxaban or warfarin for treatment of VTE.

METHODS:

We collected data on diagnostic measures, treatment, and clinical outcome of abnormal vaginal bleeding events.

MAIN OUTCOME MEASURES:

Occurrence of major and clinically relevant nonmajor (CRNM) abnormal vaginal bleeding events.

RESULTS:

In all, 628 women aged under 50 years were treated with edoxaban and 665 with warfarin. The rate of abnormal vaginal bleeding was 15/100 person-years (py) (95% CI 11-19) in women receiving edoxaban and 9/100 py (95% CI 6-12) in the warfarin group (hazard ratio: 1.7, 95% CI 1.1-2.5). Major abnormal vaginal bleeding occurred in eight (1.3%) women on edoxaban and in three (0.9%) women receiving warfarin [odds ratio (OR) 2.8; 95% CI 0.8-10.8], and CRNM abnormal vaginal bleeding occurred in 53 (8.4%) women treated with edoxaban and in 37 (5.6%) on warfarin therapy (OR 1.6, 95% CI 1.0-2.4). Over 85% of all vaginal bleeds were characterised by heavy menstrual bleeding. Major bleeds frequently required treatment, and in more than 75% of patients anticoagulant therapy was adjusted. The severity of clinical presentation and course of major and CRNM bleeds was mild in most patients.

CONCLUSIONS:

Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Reassuringly, most events could be managed conservatively and had a mild outcome.

TWEETABLE ABSTRACT:

Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.

KEYWORDS:

Abnormal uterine bleeding; edoxaban; oral anticoagulants; vaginal bleeding; venous thromboembolism; warfarin

PMID:
29940089
PMCID:
PMC6221000
DOI:
10.1111/1471-0528.15388
[Indexed for MEDLINE]
Free PMC Article

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